FDA-Device2019-11-06Class II
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Senseonics, Inc.
Hazard
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
Sold states
Nationwide
Affected count
1,344 Sensors
Manufactured in
20451 Seneca Meadows Pkwy, Germantown, MD, United States
Products
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0251-2020Don't want to check this manually?
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